Recruiting

Virtual Therapy

Sponsor:

Boston Children's Hospital

Code:

NCT07394166

Conditions

Screen Media Use

Eligibility Criteria

Sex: All

Age: 2 - 4

Healthy Volunteers: Accepted

Interventions

Brief-RSU

Study Details

Brief summary:

This study is testing a brief, virtual therapy for caregivers of preschool children. The goal is to reduce use of screen time to regulate young children's emotions and boredom, i.e. "regulatory screen use" (RSU). We expect that RSU negatively impacts young children's ability to cope with emotions and boredom. Thus, reducing RSU should improve children's self-regulation. The intervention will include three, 60-minute group sessions with caregivers, and remote data collection at three time points (pre-intervention, post-intervention, and 1-month follow-up).

Conditions

Screen Media Use

Study ID

NCT07394166

Start date

Mar 1, 2026

Status verified date

Jan, 2026

Completion date

Oct 26, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 4

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Caregiver endorses regulatory screen use
  • Child age 30-54 months at enrollment
  • English speaking

Exclusion Criteria:

  • Intellectual disability or global developmental delay
  • Autism spectrum disorder
  • Child in the custody of DCF

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

3-session, virtual group therapy

Interventions

Brief-RSU

Brief-RSU Intervention: The Brief-RSU intervention consists of three, 60-minute sessions, outlined in Table 1. Brief-RSU aims to reduce RSU while increasing adaptive caregiver tools. Treatment targets include: 1) psychoeducation, 2) scheduling screen time to consistent times, 3) "planning ahead" for times when RSU is likely to occur, and 4) teaching the RULER approach\[9, 10\] to strengthen caregiver socialization of child emotion regulation (replacement behavior).

Primary outcome measure

  • Regulatory Screen Use (RSU) [ Time Frame: Baseline; 1-month follow up (i.e., 1 month after the last workshop). ]

Central Contacts and Locations

Central contacts

Virginia Peisch, PhD

617-355-0725virginia.peisch@childrens.harvard.edu

Anne B Arnett, PhD

ArnettLab@childrens.harvard.edu

Locations

Developmental Medicine

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Virginia Peisch, phd

617-355-6000virginia.peisch@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Mar 18, 2026

Last verified

Jan, 2026

Keywords

  • childhood
  • screen time
  • parenting
  • intervention
  • self-regulation
  • preschool

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-03-18.